KR20200056719A - Composition Including Gabapentinoids for Neural Regeneration or Neural Restoration in Patient with Spinal Cord Injury - Google Patents
Composition Including Gabapentinoids for Neural Regeneration or Neural Restoration in Patient with Spinal Cord Injury Download PDFInfo
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- 208000020431 spinal cord injury Diseases 0.000 title claims abstract description 33
- 239000000203 mixture Substances 0.000 title claims abstract description 22
- 230000008929 regeneration Effects 0.000 title claims abstract description 17
- 238000011069 regeneration method Methods 0.000 title claims abstract description 17
- 230000001537 neural effect Effects 0.000 title description 9
- 210000005036 nerve Anatomy 0.000 claims abstract description 28
- UGJMXCAKCUNAIE-UHFFFAOYSA-N Gabapentin Chemical compound OC(=O)CC1(CN)CCCCC1 UGJMXCAKCUNAIE-UHFFFAOYSA-N 0.000 claims description 20
- 238000011084 recovery Methods 0.000 claims description 14
- 229960001233 pregabalin Drugs 0.000 claims description 11
- AYXYPKUFHZROOJ-ZETCQYMHSA-N pregabalin Chemical compound CC(C)C[C@H](CN)CC(O)=O AYXYPKUFHZROOJ-ZETCQYMHSA-N 0.000 claims description 11
- 229960002870 gabapentin Drugs 0.000 claims description 10
- 210000000278 spinal cord Anatomy 0.000 claims description 8
- 239000004480 active ingredient Substances 0.000 claims description 5
- 230000035771 neuroregeneration Effects 0.000 claims description 5
- 238000009472 formulation Methods 0.000 claims description 3
- OKJXJRVWXYRSAN-TXULWXBWSA-N 2-[(1r,5s,6s)-6-(aminomethyl)-3-ethyl-6-bicyclo[3.2.0]hept-3-enyl]acetic acid;benzenesulfonic acid Chemical compound OS(=O)(=O)C1=CC=CC=C1.C1C(CC)=C[C@H]2[C@](CC(O)=O)(CN)C[C@H]21 OKJXJRVWXYRSAN-TXULWXBWSA-N 0.000 claims description 2
- 229960002359 gabapentin enacarbil Drugs 0.000 claims description 2
- TZDUHAJSIBHXDL-UHFFFAOYSA-N gabapentin enacarbil Chemical compound CC(C)C(=O)OC(C)OC(=O)NCC1(CC(O)=O)CCCCC1 TZDUHAJSIBHXDL-UHFFFAOYSA-N 0.000 claims description 2
- 229940002612 prodrug Drugs 0.000 claims description 2
- 239000000651 prodrug Substances 0.000 claims description 2
- 150000003839 salts Chemical class 0.000 claims description 2
- 239000012453 solvate Substances 0.000 claims description 2
- -1 atagavalin Chemical compound 0.000 claims 1
- JXEHXYFSIOYTAH-SFYZADRCSA-N imagabalin Chemical compound CCC[C@@H](C)C[C@H](N)CC(O)=O JXEHXYFSIOYTAH-SFYZADRCSA-N 0.000 claims 1
- 229950002153 imagabalin Drugs 0.000 claims 1
- 238000000034 method Methods 0.000 abstract description 5
- 230000001939 inductive effect Effects 0.000 abstract description 3
- 230000006378 damage Effects 0.000 description 7
- 208000027418 Wounds and injury Diseases 0.000 description 6
- 208000014674 injury Diseases 0.000 description 6
- 208000028389 Nerve injury Diseases 0.000 description 4
- 230000006870 function Effects 0.000 description 4
- 210000001364 upper extremity Anatomy 0.000 description 4
- 230000006872 improvement Effects 0.000 description 3
- 230000008764 nerve damage Effects 0.000 description 3
- 210000003050 axon Anatomy 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 238000011156 evaluation Methods 0.000 description 2
- 238000002474 experimental method Methods 0.000 description 2
- 210000003141 lower extremity Anatomy 0.000 description 2
- 210000003205 muscle Anatomy 0.000 description 2
- 208000004296 neuralgia Diseases 0.000 description 2
- 230000000926 neurological effect Effects 0.000 description 2
- 230000007658 neurological function Effects 0.000 description 2
- 208000021722 neuropathic pain Diseases 0.000 description 2
- 230000001953 sensory effect Effects 0.000 description 2
- 208000001738 Nervous System Trauma Diseases 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 230000001737 promoting effect Effects 0.000 description 1
- 210000005070 sphincter Anatomy 0.000 description 1
- 210000001032 spinal nerve Anatomy 0.000 description 1
- 150000003431 steroids Chemical class 0.000 description 1
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- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
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Abstract
Description
본 발명은 가바펜티노이드를 포함하는, 척수손상 개체의 신경재생 또는 신경회복을 위한 조성물에 대한 것이다.The present invention relates to a composition for nerve regeneration or neuroregeneration of a spinal cord injury individual, comprising gabapentinoids.
임상에서 척수 손상은 손상 후 기능적 회복이 지극히 제한적이며, 그 결과 또한 개인적, 사회적으로 많은 문제점을 지속적으로 아기 할 수 있는 바 이에 대한 조기 치료는 중요하다. 그러나 실제 임상에서 이의 조기 치료를 통한 기능의 회복을 유도 할 수 있는 치료는 지극히 제한적이며, 현재까지는 고용량의 스테로이드 사용이 유일한 초기 약물치료 방법이다.In clinical practice, spinal cord injury is extremely limited in its functional recovery after injury, and as a result, it is important to address early and early treatment for many problems both personally and socially. However, in actual clinical practice, treatment that can induce the recovery of function through its early treatment is extremely limited, and to date, the use of high doses of steroids is the only initial drug treatment method.
가바펜틴 (gabapentin) 및 프레가 발린 (pregabalin)과 같은 가바펜티노이드 (Gabapentinids)는 척수 손상 환자 (spinal cord injury, SCI)의 신경병성 통증 관리에 사용되어 왔다.Gabapentinids, such as gabapentin and pregabalin, have been used to manage neuropathic pain in patients with spinal cord injury (SCI).
본 발명자들은 가바펜티노이드가 SCI 환자의 신경회복 및/또는 신경학적 기능 개선에도 효과가 있음을 발견하고, 본 발명을 완성하였다.The present inventors discovered that gabapentinoid is also effective in improving neurological function and / or neurological function in SCI patients, and completed the present invention.
본 발명의 목적은 가바펜티노이드를 유효성분으로 포함하는, 척수손상 개체의 신경재생 또는 신경회복을 위한 조성물을 제공하기 위한 것이다.An object of the present invention is to provide a composition for nerve regeneration or nerve recovery of a spinal cord injured individual comprising gabapentinoid as an active ingredient.
본 발명의 다른 목적은 척수손상 개체의 신경재생 또는 신경회복을 유도하여 척수손상을 치료하는 방법을 제공하기 위한 것이다. Another object of the present invention is to provide a method of treating spinal cord injury by inducing nerve regeneration or nerve recovery of a spinal cord injury individual.
본 발명의 또 다른 목적은 상기 조성물을 포함하는 키트 제제를 제공하기 위한 것이다.Another object of the present invention is to provide a kit formulation comprising the composition.
상기 과제를 해결하기 위해서, 본 발명은 가바펜티노이드를 유효성분으로 포함하는, 척수손상 개체의 신경재생 또는 신경회복을 위한 조성물을 제공한다.In order to solve the above problems, the present invention provides a composition for nerve regeneration or nerve recovery of a spinal cord injured individual comprising gabapentinoid as an active ingredient.
본 발명에서 용어 "신경재생(neural regeneration)"이란, 절단된 축삭(axonotmesis)의 말단부에서 원위부로 축삭이 성장하는 것을 의미한다.The term "neural regeneration" in the present invention means that the axon grows from the distal end to the distal end of the cut axon (axonotmesis).
본 발명에서 용어 "신경보호(neural protection)"란, 정상 신경이나 손상된 신경이 더 이상 손상되지 않도록 취하는 조치를 의미한다.In the present invention, the term "neural protection (neural protection)" means an action to take so that normal nerves or damaged nerves are no longer damaged.
본 발명에서 용어 "신경회복(neural restoration)"이란, 손상된 신경의 기능이 정상화되거나 정상화되는 과정을 의미한다.In the present invention, the term "neural restoration (neural restoration)" means a process in which the function of a damaged nerve is normalized or normalized.
상기 가바펜티노이드는 가바펜틴, 프레가발린, 아타가발린, 이마가발린, DS-5565 및 가바펜틴 에나카르빌(Gabapentin enacarbil) 또는 그의 약학적으로 허용가능한 염, 이성질체, 전구약물 또는 용매화물일 수 있다.The gabapentinoid may be gabapentin, pregabalin, atagavalin, imagavalin, DS-5565 and gabapentin enacarbil or a pharmaceutically acceptable salt, isomer, prodrug or solvate thereof. .
상기 가바펜타노이드는 척수 손상 개체에게 150 내지 2400 mg/day 투여될 수 있다.The gabapentanoid may be administered to a subject with spinal cord injury between 150 and 2400 mg / day.
상기 가바펜타노이드는 척수 손상 개체에게 60일 이상 투여될 수 있다.The gabapentanoid may be administered to individuals with spinal cord injury for at least 60 days.
상기 가바펜타노이드는 척수 손상 개체에게 30일 내지 60일 투여될 수 있다.The gabapentanoid may be administered to an individual with spinal cord injury from 30 days to 60 days.
상기 가바펜타노이드는 프레가발린일 수 있다.The gabapentanoide may be pregabalin.
상기 프레가발린은 척수 손상 개체에게 150 내지 600 mg/day의 용량으로 30일 내지 60일 투여될 수 있다. The pregabalin may be administered to an individual with spinal cord injury at a dose of 150 to 600 mg / day for 30 to 60 days.
상기 가바펜타노이드는 가바펜틴일 수 있다.The gabapentanoid may be gabapentin.
상기 가바펜틴은 척수 손상 개체에게 300 내지 2400 mg/day의 용량으로 30일 내지 60일 투여될 수 있다.The gabapentin may be administered to an individual with spinal cord injury at a dose of 300 to 2400 mg / day for 30 to 60 days.
다른 측면에서 본 발명은 척수 손상 개체의 신경재생 또는 신경회복에 유효한 양의 가바펜티노이드를 투여하여, 척수손상 개체의 신경재생 또는 신경회복을 유도하여 척수손상을 치료하는 방법을 제공한다.In another aspect, the present invention provides a method of treating spinal cord injury by inducing nerve regeneration or nerve recovery of a spinal cord injury object by administering an amount of gabapentinoid effective for nerve regeneration or nerve recovery of a spinal cord injury object.
또 다른 측면에서 본 발명은 i) 가바펜티노이드를 유효성분으로 포함하는, 척수손상 개체의 신경재생 또는 신경회복을 위한 조성물과 ii) 상기 조성물의 사용설명서를 포함하는 키트 제제를 제공한다.In another aspect, the present invention provides a kit formulation comprising i) a composition for nerve regeneration or neuroregeneration of a spinal cord injury individual comprising gabapentinoid as an active ingredient and ii) instructions for use of the composition.
상기 사용설명서에는 상기 조성물을 척수 손상 개체에게 150 내지 2400 mg/day 용량으로 60일 이상 투여할 수 있다는 내용이 기재될 수 있다.The instruction manual may describe that the composition can be administered to individuals with spinal cord injury at a dose of 150 to 2400 mg / day for at least 60 days.
또한 상기 사용설명서에는 프레가발린을 포함하는 조성물이 척수 손상 개체에게 150 내지 600 mg/day의 용량으로 30일 내지 60일 투여될 수 있다는 내용이 기재될 수 있다.In addition, the instruction manual may describe that the composition containing pregabalin can be administered to an individual with spinal cord injury at a dose of 150 to 600 mg / day for 30 to 60 days.
또한 상기 사용설명서에는 가바펜틴을 포함하는 조성물이 척수 손상 개체에게 300 내지 2400 mg/day의 용량으로 30일 내지 60일 투여될 수 있다는 내용이 기재될 수 있다.In addition, the instruction manual may describe that the composition containing gabapentin can be administered to an individual with spinal cord injury at a dose of 300 to 2400 mg / day for 30 to 60 days.
덧붙여 상기한 과제의 해결수단은, 본 발명의 특징을 모두 열거한 것이 아니다. 본 발명의 다양한 특징과 그에 따른 장점과 효과는 아래의 구체적인 실시형태를 참조하여 보다 상세하게 이해될 수 있을 것이다.In addition, the solution means of the above-mentioned subject does not list all the characteristics of this invention. Various features of the present invention and advantages and effects thereof may be understood in more detail with reference to specific embodiments below.
본 발명에 따른 가바펜티노이드를 포함하는 조성물은 척수 신경 손상 환자의 신경재생 및/또는 신경회복 효과를 제공한다.The composition comprising gabapentinoid according to the present invention provides a neuroregeneration and / or neurorecovery effect in patients with spinal cord nerve injury.
도 1은 본 발명에 따른 실험 방법을 모식적으로 나타낸 것이다.
도 2는 본 발명의 일 실시예에 따른 분석항목을 설명한 것이다.1 schematically shows an experimental method according to the present invention.
2 illustrates an analysis item according to an embodiment of the present invention.
이하, 첨부된 도면을 참조하여 본 발명이 속하는 기술분야에서 통상의 지식을 가진 자가 본 발명을 용이하게 실시할 수 있도록 바람직한 실시예를 상세히 설명한다. 다만, 본 발명의 바람직한 실시예를 상세하게 설명함에 있어, 관련된 공지 기능 또는 구성에 대한 구체적인 설명이 본 발명의 요지를 불필요하게 흐릴 수 있다고 판단되는 경우에는 그 상세한 설명을 생략한다. 하기 실시예는 본 발명의 내용을 구체화하기 위한 것일 뿐 이에 의해 본 발명이 한정되는 것은 아니다.Hereinafter, preferred embodiments will be described in detail with reference to the accompanying drawings so that those skilled in the art to which the present invention pertains can easily implement the present invention. However, in the detailed description of the preferred embodiment of the present invention, when it is determined that a detailed description of related known functions or configurations may unnecessarily obscure the subject matter of the present invention, the detailed description will be omitted. The following examples are only intended to materialize the contents of the present invention, and the present invention is not limited thereby.
실시예 1: 실험 방법Example 1: Experimental method
신경병성 통증에 관계없이, 척수신경 손상 시점부터 손상 후 2 개월까지, 다양한 시점에서 73 명의 SCI 환자가 가바펜틴 (n = 7) 또는 프레가발린 (n = 66)을 투여 받았고 가바펜티노이드를 투여받지 않은 9 명의 SCI 환자를 대조군으로 사용했다(표 1, 도 1). Regardless of neuropathic pain, 73 SCI patients received gabapentin (n = 7) or pregabalin (n = 66) at various time points, from the time of spinal nerve injury to 2 months after injury, and no gabapentinoids Nine non-SCI patients were used as controls (Table 1, Figure 1).
[표 1][Table 1]
프레가발린과 가바펜틴의 복욕량과 기간은 표 2에 나타내었다.Table 2 shows the amount and duration of pregabalin and gabapentin.
[표 2] 피험자에게 사용된 가바펜티노이드의 양과 기간 Table 2: Amount and duration of gabapentinoids used in subjects
모든 피실험자는 부상 후 1-2개월 동안 척수 손상의 신경 분류에 관한 국제 표준 (ISNCSCI)을 사용하여 신경 학적 평가를 실시하였고, 한국판 Modified Barthel Index (K-MBI)와 Functional Independence Measure (FIM)에 기초한 기능 평가를 수행하였다. All subjects were subjected to neurological evaluation using the International Standard for Neural Classification of Spinal Cord Injury (ISNCSCI) for 1-2 months after injury, based on the Korean version of the Modified Barthel Index (K-MBI) and Functional Independence Measure (FIM). Functional evaluation was performed.
실시예 2: 결과Example 2: Results
추적 관찰 기간 동안 모든 환자에서 상지(upper extremity)의 운동 점수는 가바펜티노이드 투여군과 상관없이 증가하였으나, 가바펜티노이드 복용 군에서만 하지(lower extremity) 운동 점수와 상지와 하지의 감각 점수가 증가 하였다 (표 3).During the follow-up period, the exercise score of the upper extremity increased in all patients, regardless of the gabapentinoid-administered group, but the lower extremity exercise score and the upper and lower extremity sensory scores increased only in the gabapentinoid-treated group ( Table 3).
[표 3] 모든 피험자의 신경 상태 (운동 및 감각 점수)의 변화[Table 3] Changes in neural status (motor and sensory scores) of all subjects
가바펜티노이드의 용량별 분석 결과는 다음 표 4와 같다(표 4의 각 항목의 의미는 도 2 참고). The analysis results for each dose of gabapentinoid are shown in Table 4 below (see FIG. 2 for the meaning of each item in Table 4).
[표 4][Table 4]
프레가발린의 용량별 투여 결과는 다음 표 5와 같다(표 5의 각 항목의 의미는 도 2 참고).The results of administration of pregabalin by dose are shown in Table 5 below (refer to Figure 2 for the meaning of each item in Table 5).
[표 5][Table 5]
표 4 및 5를 통해, 고용량을 투여한 환자들에서 상지의 근력 회복이 증가(UER, UEL)되고, 운동능력에 대한 NLI (신경손상레벨)의 회복 정도가 더 증가(NLIM)됨을 알 수 있다. 즉, 가바펜티노이드는 신경학적 회복, 특히 운동능력의 향상을 가져온다.Through Tables 4 and 5, it can be seen that the recovery of muscle strength of the upper extremities is increased (UER, UEL) and the degree of recovery of NLI (nerve damage level) for exercise ability is further increased (NLIM) in patients who are administered high doses. . In other words, gabapentinoids lead to neurological recovery, especially improvement in motor skills.
K-MBI를 이용한 기능 점수는 대조군에서 개선되지 않았으며, 가바펜티노이드 사용자에서는 K-MBI 점수가 향상되었다(표 6).The functional score using K-MBI was not improved in the control group, and the K-MBI score was improved in the gabapentinoid user (Table 6).
[표 6][Table 6]
가바펜티노이드 사용자 중 조기 사용(투여) (부상 후 24 시간 이내)과 후기 사용 (부상 후 24 시간 이상)을 비교할 때 K-MBI 및 FIM 점수는 두 그룹 모두에서 증가했다 (표 7).K-MBI and FIM scores increased in both groups when comparing early use (administered) (within 24 hours after injury) and late use (over 24 hours after injury) among gabapentinoid users (Table 7).
[표 7][Table 7]
30일 미만의 투여(short duration) 및 30일 이상의 투여(long duration)으로 나누어서, 가바펜티노이드의 투여 기간 별 결과는 다음 표 8과 같다(표 8의 각 항목의 의미는 도 2 참고).Divided into short duration of 30 days (short duration) and longer than 30 days (long duration), the results for each administration period of gabapentinoid are shown in Table 8 below (see the meaning of each item in Table 8 in FIG.
[표 8][Table 8]
상기 표 8의 결과, 30일 이상 투여한 환자들에서 상지의 근력 회복이 증가(UEL, UEMS)되고, FIM 지수상 self care 및 sphincter 기능이 증가(FIMSC, FIMSP)되었음을 확인할 수 있었다. As a result of Table 8, it was confirmed that in patients who were administered for 30 days or more, muscle recovery of the upper limbs was increased (UEL, UEMS), and self care and sphincter functions were increased (FIMSC, FIMSP) on the FIM index.
AIS(Abbreviated Injury Scale) 개선은 가바펜티노이드 사용자에서 대조군보다 더 많이 나타났다. (특히 초기 AIS C, 표 9).The AIS (Abbreviated Injury Scale) improvement was greater in gabapentinoid users than in the control group. (Especially early AIS C, Table 9).
[표 9] 입원 및 퇴원시 AIS 손상 상태 분포 [Table 9] Distribution of AIS damage status at hospitalization and discharge
이상 살펴본 바와 같이, 가바펜티노이드는 SCI 환자의 신경학 및 기능 향상을 촉진시키는 데 효과가 있다.As described above, gabapentinoids are effective in promoting neurology and functional improvement in SCI patients.
Claims (8)
Composition containing gabapentinoid as an active ingredient, nerve regeneration or neuroregeneration of a spinal cord injury individual.
상기 가바펜티노이드는 가바펜틴, 프레가발린, 아타가발린, 이마가발린, DS-5565 및 가바펜틴 에나카르빌(Gabapentin enacarbil) 또는 그의 약학적으로 허용가능한 염, 이성질체, 전구약물 또는 용매화물인, 척수손상 개체의 신경재생 또는 신경회복을 위한 조성물.
According to claim 1,
The gabapentinoid is spinal cord, which is gabapentin, pregabalin, atagavalin, imagabalin, DS-5565 and gabapentin enacarbil or a pharmaceutically acceptable salt, isomer, prodrug or solvate thereof. A composition for nerve regeneration or nerve recovery of a damaged individual.
상기 가바펜타노이드는 척수 손상 개체에게 150 내지 2400 mg/day 투여되는 것인, 척수손상 개체의 신경재생 또는 신경회복을 위한 조성물.
According to claim 1,
The gabapentanoid is to be administered to an individual with a spinal cord injury between 150 and 2400 mg / day, a composition for nerve regeneration or nerve recovery of a spinal cord injury individual.
상기 가바펜타노이드는 척수 손상 개체에게 60일 이상 투여되는 것인, 척수손상 개체의 신경재생 또는 신경회복을 위한 조성물.
According to claim 1,
The gabapentanoid is administered to a subject with spinal cord injury for at least 60 days, a composition for nerve regeneration or nerve recovery of a spinal cord injury subject.
상기 가바펜타노이드는 척수 손상 개체에게 30일 내지 60일 투여되는 것인, 척수손상 개체의 신경재생 또는 신경회복을 위한 조성물.
According to claim 1,
The gabapentanoid is administered to the spinal cord injured individual 30 days to 60 days, a composition for nerve regeneration or neurorecovery in a spinal cord injured individual.
상기 가바펜타노이드는 프레가발린이고, 상기 프레가발린은 척수 손상 개체에게 150 내지 600 mg/day의 용량으로 30일 내지 60일 투여되는 것인, 척수손상 개체의 신경재생 또는 신경회복을 위한 조성물.
According to claim 1,
The gabapentanoid is pregabalin, and the pregabalin is administered to the spinal cord injured individual at a dose of 150 to 600 mg / day for 30 to 60 days. .
상기 가바펜타노이드는 가바펜틴이고, 상기 가바펜틴은 척수 손상 개체에게 300 내지 2400 mg/day의 용량으로 30일 내지 60일 투여되는 것인, 척수손상 개체의 신경재생 또는 신경회복을 위한 조성물.
According to claim 1,
The gabapentinoid is gabapentin, and the gabapentin is administered to a spinal cord injured individual at a dose of 300 to 2400 mg / day for 30 to 60 days.
i) A kit formulation comprising a composition for nerve regeneration or neuroregeneration of a spinal cord injury individual comprising gabapentinoid as an active ingredient and ii) instructions for use of said composition.
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PCT/KR2018/014052 WO2020101078A1 (en) | 2018-11-15 | 2018-11-16 | Composition containing gabapentinoid for nerve regeneration or nerve rehabilitation of individual with spinal cord injury |
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KR20100015014A (en) * | 2008-08-04 | 2010-02-12 | 가톨릭대학교 산학협력단 | Pharmaceutical composition for treating spinal cord injury comprising pregabalin |
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